U.S. patent number 9,901,274 [Application Number 15/406,627] was granted by the patent office on 2018-02-27 for electrocardiography patch.
This patent grant is currently assigned to Bardy Diagnostics, Inc.. The grantee listed for this patent is Bardy Diagnostics, Inc.. Invention is credited to Gust H. Bardy, Jon Mikalson Bishay, Jason Felix.
United States Patent |
9,901,274 |
Bishay , et al. |
February 27, 2018 |
Electrocardiography patch
Abstract
An electrocardiography patch is provided. A flexible backing is
formed of an elongated strip of stretchable material and a pair of
electrodes is respectively affixed on a contact surface of each end
of the elongated strip. A flexible circuit is affixed on each end
of the elongated strip and includes a pair of circuit traces
electrically coupled to each electrode. A non-conductive receptacle
is securely adhered on the one end of the elongated strip opposite
the contact surface and formed to removably receive an
electrocardiography monitor and house a battery. Electrical pads
are provided on a bottom surface of the non-conductive receptacle
to interface with electrical contacts protruding from the
electrocardiography monitor. A pair of the electrical pads is
formed to electrically couple with the electrodes. A pair of
battery leads is formed on the non-conductive receptacle to
electrically interface the battery to another pair of the
electrical pads.
Inventors: |
Bishay; Jon Mikalson (Seattle,
WA), Bardy; Gust H. (Carnation, WA), Felix; Jason
(Vashon Island, WA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Bardy Diagnostics, Inc. |
Charlotte |
NC |
US |
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Assignee: |
Bardy Diagnostics, Inc.
(Seattle, WA)
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Family
ID: |
52691529 |
Appl.
No.: |
15/406,627 |
Filed: |
January 13, 2017 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20170188871 A1 |
Jul 6, 2017 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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14080717 |
Nov 14, 2013 |
9545204 |
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61882403 |
Sep 25, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
5/259 (20210101); A61B 5/349 (20210101); A61B
5/6801 (20130101); A61B 5/6823 (20130101); A61B
5/02055 (20130101); A61B 5/35 (20210101); A61B
5/1116 (20130101); A61B 5/1117 (20130101); A61B
5/0022 (20130101); A61B 5/316 (20210101); A61B
5/0006 (20130101); A61B 5/282 (20210101); A61B
5/6833 (20130101); A61B 5/335 (20210101); A61B
5/4809 (20130101); A61B 5/1118 (20130101); A61B
5/0816 (20130101); A61B 2560/0271 (20130101); A61B
2562/164 (20130101); A61B 2562/0219 (20130101); A61B
2505/07 (20130101); A61B 5/14532 (20130101); A61B
2560/045 (20130101); A61B 5/01 (20130101); A61B
5/7455 (20130101); G01N 27/307 (20130101); A61B
5/14551 (20130101); A61B 5/091 (20130101); A61B
5/14542 (20130101); A61B 5/087 (20130101); A61B
2560/0412 (20130101); A61B 5/021 (20130101) |
Current International
Class: |
A61B
5/04 (20060101); A61B 5/0408 (20060101); A61B
5/0205 (20060101); A61B 5/00 (20060101); A61B
5/087 (20060101); A61B 5/021 (20060101); A61B
5/08 (20060101); A61B 5/145 (20060101); A61B
5/091 (20060101) |
Field of
Search: |
;600/372,382,384,386,388,390-393,508-509 |
References Cited
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|
Primary Examiner: Stoklosa; Joseph
Assistant Examiner: Antiskay; Brian M
Attorney, Agent or Firm: Inouye; Patrick J. S. Wittman;
Krista A.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This U.S. patent application is a continuation of U.S. patent
application Ser. No. 14/080,717, filed Nov. 14, 2013, which claims
priority under 35 U.S.C. .sctn. 119(e) to U.S. Provisional Patent
application Ser. No. 61/882,403, filed Sep. 25, 2013, the
disclosure of which is incorporated by reference.
Claims
What is claimed is:
1. An electrocardiography patch, comprising: a flexible backing
formed of an elongated strip of stretchable material; a pair of
electrodes respectively affixed to and conductively exposed on a
contact surface of each end of the elongated strip; a flexible
circuit affixed on each end to the elongated strip and comprising a
pair of circuit traces both originating within one of the ends of
the elongated strip and electrically coupled to each electrode; a
non-conductive receptacle securely adhered on the one end of the
elongated strip opposite the contact surface and formed to
removably receive an electrocardiography monitor and house a
battery below the received electrocardiography monitor; electrical
pads provided within a moisture-resistant seal formed on a bottom
surface of the non-conductive receptacle to interface with
electrical contacts protruding from a bottom surface of the
electrocardiography monitor and a pair of the electrical pads
formed to electrically couple with the electrodes via the circuit
traces; and a pair of battery leads formed on the non-conductive
receptacle to electrically interface the battery to another pair of
the electrical pads.
2. An electrocardiography patch according to claim 1, further
comprising: one of the electrodes being disposed for being adhered
to a region overlying the Xiphoid process on a patient's chest; and
an other of the electrodes being disposed for being adhered to the
region near the manubrium on the patient's chest oriented centrally
(in the midline) along the sternum upwards from the one
electrode.
3. An electrocardiography patch according to claim 1, further
comprising: an upper part of the elongated strip defined on one end
of the flexible backing and sized to be affixed to the bottom
surface of the non-conductive receptacle, the other of the
electrodes being affixed to and conductively exposed on the contact
surface of the upper part; and a lower part of the elongated strip
defined on another end of the flexible backing; the one of the
electrodes being affixed to and conductively exposed on the contact
surface of the lower part, wherein the lower part of the elongated
strip is provided for being adhered to the region overlying the
Xiphoid process on a patient's chest with the narrow longitudinal
midsection oriented centrally (in the midline) along the sternum
and the upper part of the elongated strip oriented upwards towards
the manubrium.
4. An electrocardiography patch according to claim 1, further
comprising: a non-irritating adhesive dressing at least partially
coated on each end of the elongated strip on the contact
surface.
5. An electrocardiography patch according to claim 4, further
comprising: a contoured surface comprised on the non-irritating
adhesive dressing on at least one end of the elongated strip.
6. An electrocardiography patch according to claim 1, further
comprising: a plurality of fasteners comprised on the
non-conductive receptacle and oriented to securely receive and to
hold captive the electrocardiography monitor into the
non-conductive receptacle.
7. An electrocardiography patch according to claim 1, further
comprising: at least one of an SpO2 sensor, a blood pressure
sensor, a temperature sensor, respiratory rate sensor, a glucose
sensor, an air flow sensor, and a volumetric pressure sensor
provided to supplement the electrocardiography monitor by one of
direct incorporation into the electrocardiography monitor and
direct receipt on the non-conductive receptacle.
8. An electrocardiography patch according to claim 1, further
comprising: a liner shaped to cover the contact surface of the
flexible backing.
9. An electrocardiography patch according to claim 1, wherein the
flexible circuit is adhered to one of the contact surface of the
flexible backing and a surface opposite the contact surface of the
flexible backing.
10. An electrocardiography patch according to claim 1, wherein the
electrocardiography monitor draws power externally from the battery
provided in the non-conductive receptacle.
11. An electrocardiography and physiological sensor monitor,
comprising: a disposable extended wear electrode patch comprising:
a flexible backing formed of an elongated strip of stretchable
material; a pair of electrodes respectively affixed to and
conductively exposed on a contact surface of each end of the
elongated strip; a flexible circuit affixed on each end to the
elongated strip and comprising a pair of circuit traces both
originating within one of the ends of the elongated strip and
electrically coupled to each electrode; a non-conductive receptacle
securely adhered on the one end of the elongated strip opposite the
contact surface and formed to house a battery; electrical pads
provided within a moisture-resistant seal formed on a bottom
surface of the non-conductive receptacle and a pair of the
electrical pads formed to electrically couple with the electrodes
via the circuit traces; and a pair of battery leads formed on the
non-conductive receptacle to electrically interface the battery to
another pair of the electrical pads; and a reusable
electrocardiography monitor having a sealed housing adapted to be
removably secured into the non-conductive receptacle, wherein the
sealed housing comprises a cavity on a bottom surface to
accommodate the battery on the extended wear electrode patch and
protruding electrical contacts that interface with the electrical
pads on the non-conductive receptacle.
12. An electrocardiography and physiological sensor monitor
according to claim 11, further comprising: one of the electrodes
being disposed for being adhered to a region overlying the Xiphoid
process on a patient's chest; and an other of the electrodes being
disposed for being adhered to the region near the manubrium on the
patient's chest oriented centrally (in the midline) along the
sternum upwards from the one electrode.
13. An electrocardiography and physiological sensor monitor
according to claim 11, further comprising: an upper part of the
elongated strip defined on one end of the flexible backing and
sized to be affixed to the bottom surface of the non-conductive
receptacle, the other of the electrodes being affixed to and
conductively exposed on the contact surface of the upper part; and
a lower part of the elongated strip defined on another end of the
flexible hacking; the one of the electrodes being affixed to and
conductively exposed on the contact surface of the lower part,
wherein the lower part of the elongated strip is provided for being
adhered to the region overlying the Xiphoid process on a patient's
chest with the narrow longitudinal midsection oriented centrally
(in the midline) along the sternum and the upper part of the
elongated strip oriented upwards towards the manubrium.
14. An electrocardiography and physiological sensor monitor
according to claim 11, further comprising: a non-irritating
adhesive dressing at least partially coated on each end of the
elongated strip on the contact surface.
15. An electrocardiography and physiological sensor monitor
according to claim 14, further comprising: a contoured surface
comprised on the non-irritating adhesive dressing on at least one
end of the elongated strip.
16. An electrocardiography and physiological sensor monitor
according to claim 11, further comprising: a plurality of fasteners
comprised on the non-conductive receptacle and oriented to securely
receive and to hold captive the electrocardiography monitor into
the non-conductive receptacle.
17. An electrocardiography and physiological sensor monitor
according to claim 11, further comprising: at least one of an SpO2
sensor, a blood pressure sensor, a temperature sensor, respiratory
rate sensor, a glucose sensor, an air flow sensor, and a volumetric
pressure sensor provided to supplement the electrocardiography
monitor by one of direct incorporation into the electrocardiography
monitor and direct receipt on the non-conductive receptacle.
18. An electrocardiography and physiological sensor monitor
according to claim 11, further comprising: a liner shaped to cover
the contact surface of the flexible backing.
19. An electrocardiography and physiological sensor monitor
according to claim 11, wherein the flexible circuit is adhered to
one of the contact surface of the flexible backing and a surface
opposite the contact surface of the flexible backing.
20. An electrocardiography and physiological sensor monitor
according to claim 11, wherein the electrocardiography monitor
draws power externally from the battery provided in the
non-conductive receptacle.
Description
FIELD
This application relates in general to electrocardiographic
monitoring and, in particular, to an electrocardiography patch.
BACKGROUND
The heart emits electrical signals as a by-product of the
propagation of the action potentials that trigger depolarization of
heart fibers. An electrocardiogram (ECG) measures and records such
electrical potentials to visually depict the electrical activity of
the heart over time. Conventionally, a standardized set format
12-lead configuration is used by an ECG machine to record cardiac
electrical signals from well-established traditional chest
locations. Electrodes at the end of each lead are placed on the
skin over the anterior thoracic region of the patient's body to the
lower right and to the lower left of the sternum, on the left
anterior chest, and on the limbs. Sensed cardiac electrical
activity is represented by PQRSTU waveforms that can be interpreted
post-ECG recordation to derive heart rate and physiology. The
P-wave represents atrial electrical activity. The QRSTU components
represent ventricular electrical activity.
An ECG is a tool used by physicians to diagnose heart problems and
other potential health concerns. An ECG is a snapshot of heart
function, typically recorded over 12 seconds, that can help
diagnose rate and regularity of heartbeats, effect of drugs or
cardiac devices, including pacemakers and implantable
cardioverter-defibrillators (ICDs), and whether a patient has heart
disease. ECGs are used in-clinic during appointments, and, as a
result, are limited to recording only those heart-related aspects
present at the time of recording. Sporadic conditions that may not
show up during a spot ECG recording require other means to diagnose
them. These disorders include fainting or syncope; rhythm
disorders, such as tachyarrhythmias and bradyarrhythmias; apneic
episodes; and other cardiac and related disorders. Thus, an ECG
only provides a partial picture and can be insufficient for
complete patient diagnosis of many cardiac disorders.
Diagnostic efficacy can be improved, when appropriate, through the
use of long-term extended ECG monitoring. Recording sufficient ECG
and related physiology over an extended period is challenging, and
often essential to enabling a physician to identify events of
potential concern. A 30-day observation day period is considered
the "gold standard" of ECG monitoring, yet achieving a 30-day
observation day period has proven unworkable because such ECG
monitoring systems are arduous to employ, cumbersome to the
patient, and excessively costly. Ambulatory monitoring in-clinic is
implausible and impracticable. Nevertheless, if a patient's ECG
could be recorded in an ambulatory setting, thereby allowing the
patient to engage in activities of daily living, the chances of
acquiring meaningful information and capturing an abnormal event
while the patient is engaged in normal activities becomes more
likely to be achieved.
For instance, the long-term wear of ECG electrodes is complicated
by skin irritation and the inability ECG electrodes to maintain
continual skin contact after a day or two. Moreover, time, dirt,
moisture, and other environmental contaminants, as well as
perspiration, skin oil, and dead skin cells from the patient's
body, can get between an ECG electrode, the non-conductive adhesive
used to adhere the ECG electrode, and the skin's surface. All of
these factors adversely affect electrode adhesion and the quality
of cardiac signal recordings. Furthermore, the physical movements
of the patient and their clothing impart various compressional,
tensile, and torsional forces on the contact point of an ECG
electrode, especially over long recording times, and an inflexibly
fastened ECG electrode will be prone to becoming dislodged.
Moreover, dislodgment may occur unbeknownst to the patient, making
the ECG recordings worthless. Further, some patients may have skin
that is susceptible to itching or irritation, and the wearing of
ECG electrodes can aggravate such skin conditions. Thus, a patient
may want or need to periodically remove or replace ECG electrodes
during a long-term ECG monitoring period, whether to replace a
dislodged electrode, reestablish better adhesion, alleviate itching
or irritation, allow for cleansing of the skin, allow for showering
and exercise, or for other purpose. Such replacement or slight
alteration in electrode location actually facilitates the goal of
recording the ECG signal for long periods of time.
Conventionally, Holter monitors are widely used for long-term
extended ECG monitoring. Typically, they are often used for only
24-48 hours. A typical Holter monitor is a wearable and portable
version of an ECG that include cables for each electrode placed on
the skin and a separate battery-powered ECG recorder. The cable and
electrode combination (or leads) are placed in the anterior
thoracic region in a manner similar to what is done with an
in-clinic standard ECG machine. The duration of a Holter monitoring
recording depends on the sensing and storage capabilities of the
monitor, as well as battery life. A "looping" Holter (or event)
monitor can operate for a longer period of time by overwriting
older ECG tracings, thence "recycling" storage in favor of extended
operation, yet at the risk of losing event data. Although capable
of extended ECG monitoring, Holter monitors are cumbersome,
expensive and typically only available by medical prescription,
which limits their usability. Further, the skill required to
properly place the electrodes on the patient's chest hinders or
precludes a patient from replacing or removing the precordial leads
and usually involves moving the patient from the physician office
to a specialized center within the hospital or clinic.
The ZIO XT Patch and ZIO Event Card devices, manufactured by
iRhythm Tech., Inc., San Francisco, Calif., are wearable stick-on
monitoring devices that are typically worn on the upper left
pectoral region to respectively provide continuous and looping ECG
recording. The location is used to simulate surgically implanted
monitors. Both of these devices are prescription-only and for
single patient use. The ZIO XT Patch device is limited to a 14-day
monitoring period, while the electrodes only of the ZIO Event Card
device can be worn for up to 30 days. The ZIO XT Patch device
combines both electronic recordation components and physical
electrodes into a unitary assembly that adheres to the patient's
skin. The ZIO XT Patch device uses adhesive sufficiently strong to
support the weight of both the monitor and the electrodes over an
extended period of time and to resist disadherance from the
patient's body, albeit at the cost of disallowing removal or
relocation during the monitoring period. The ZIO Event Card device
is a form of downsized Holter monitor with a recorder component
that must be removed temporarily during baths or other activities
that could damage the non-waterproof electronics. Both devices
represent compromises between length of wear and quality of ECG
monitoring, especially with respect to ease of long term use,
female-friendly fit, and quality of atrial (P-wave) signals.
Therefore, a need remains for an extended wear continuously
recording ECG monitor practicably capable of being worn for a long
period of time, especially in women where breast anatomy can
interfere with signal quality in both men and women and capable of
recording atrial signals reliably.
A further need remains for a device capable of recording signals
ideal for arrhythmia discrimination, especially a device designed
for atrial activity recording.
SUMMARY
Physiological monitoring can be provided through a wearable monitor
that includes two components, a flexible extended wear electrode
patch and a removable reusable monitor recorder. The wearable
monitor sits centrally (in the midline) on the patient's chest
along the sternum oriented top-to-bottom. The placement of the
wearable monitor in a location at the sternal midline (or
immediately to either side of the sternum), with its unique narrow
"hourglass"-like shape, significantly improves the ability of the
wearable monitor to cutaneously sense cardiac electric signals,
particularly the P-wave (or atrial activity) and, to a lesser
extent, the QRS interval signals in the ECG waveforms indicating
ventricular activity. The electrode patch is shaped to fit
comfortably and conformal to the contours of the patient's chest
approximately centered on the sternal midline. To counter the
dislodgment due to compressional and torsional forces, a layer of
non-irritating adhesive, such as hydrocolloid, is provided at least
partially on the underside, or contact, surface of the electrode
patch, but only on the electrode patch's distal and proximal ends.
To counter dislodgment due to tensile and torsional forces, a
strain relief is defined in the electrode patch's flexible circuit
using cutouts partially extending transversely from each opposite
side of the flexible circuit and continuing longitudinally towards
each other to define in `S`-shaped pattern. Each of these
components are distinctive and allow for comfortable and extended
wear, especially by women, where breast mobility would otherwise
interfere with monitor use and comfort.
One embodiment provides an extended wear electrocardiography patch.
A flexible backing is formed of an elongated strip of stretchable
material with a narrow longitudinal midsection evenly tapering
inward from both ends. The elongated strip is adherable only on
each end of a contact surface to serve as a crimp relief to
facilitate compression of the narrow longitudinal midsection in
response to compressional and torsional forces. A pair of
electrocardiographic electrodes is respectively affixed to and
conductively exposed on the contact surface of each end of the
elongated strip. A flexible circuit is affixed on each end to the
elongated strip. The flexible circuit includes a pair of circuit
traces both originating within one of the ends of the elongated
strip and which are electrically coupled to each
electrocardiographic electrode. A laterally-extendable strain
relief is defined in the flexible circuit and formed to facilitate
extension and rotation of the flexible circuit in response to
tensile and torsional forces. A non-conductive receptacle is
securely adhered on the one end of the elongated strip opposite the
contact surface and is formed to removably receive an
electrocardiography monitor. The non-conductive receptacle includes
electrode terminals aligned to electrically interface the pair of
circuit traces to the electrocardiography monitor.
A further embodiment provides an electrocardiography patch. A
flexible backing is formed of an elongated strip of stretchable
material and a pair of electrodes is respectively affixed on a
contact surface of each end of the elongated strip. A flexible
circuit is affixed on each end of the elongated strip and includes
a pair of circuit traces electrically coupled to each electrode. A
non-conductive receptacle is securely adhered on the one end of the
elongated strip opposite the contact surface and formed to
removably receive an electrocardiography monitor and house a
battery. Electrical pads are provided on a bottom surface of the
non-conductive receptacle to interface with electrical contacts
protruding from the electrocardiography monitor. A pair of the
electrical pads is formed to electrically couple with the
electrodes. A pair of battery leads is formed on the non-conductive
receptacle to electrically interface the battery to another pair of
the electrical pads.
The monitoring patch is especially suited to the female anatomy.
The narrow longitudinal midsection can fit nicely within the
intermammary cleft of the breasts without inducing discomfort,
whereas conventional patch electrodes are wide and, if adhesed
between the breasts, would cause chafing, irritation, frustration,
and annoyance, leading to low patient compliance.
The foregoing aspects enhance ECG monitoring performance and
quality facilitating long-term ECG recording, critical to accurate
arrhythmia diagnosis.
In addition, the foregoing aspects enhance comfort in women (and
certain men), but not irritation of the breasts, by placing the
monitoring patch in the best location possible for optimizing the
recording of cardiac signals from the atrium, another feature
critical to proper arrhythmia diagnosis.
Still other embodiments will become readily apparent to those
skilled in the art from the following detailed description, wherein
are described embodiments by way of illustrating the best mode
contemplated. As will be realized, other and different embodiments
are possible and the embodiments' several details are capable of
modifications in various obvious respects, all without departing
from their spirit and the scope. Accordingly, the drawings and
detailed description are to be regarded as illustrative in nature
and not as restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1 and 2 are diagrams showing, by way of examples, an extended
wear electrocardiography monitor, including an extended wear
electrode patch in accordance with one embodiment, respectively
fitted to the sternal region of a female patient and a male
patient.
FIG. 3 is a perspective view showing an extended wear electrode
patch in accordance with one embodiment with a monitor recorder
inserted.
FIG. 4 is a perspective view showing the extended wear electrode
patch of FIG. 3 without a monitor recorder inserted.
FIG. 5 is a top view showing the flexible circuit of the extended
wear electrode patch of FIG. 3.
FIG. 6 is a perspective view showing the extended wear electrode
patch in accordance with a further embodiment.
FIG. 7 is an exploded view showing the component layers of the
electrode patch of FIG. 3.
FIG. 8 is a bottom plan view of the extended wear electrode patch
of FIG. 3 with liner partially peeled back.
DETAILED DESCRIPTION
Physiological monitoring can be provided through a wearable monitor
that includes two components, a flexible extended wear electrode
patch and a removable reusable monitor recorder. FIGS. 1 and 2 are
diagrams showing, by way of examples, an extended wear
electrocardiography monitor 12, including an extended wear
electrode patch 15 in accordance with one embodiment, respectively
fitted to the sternal region of a female patient 10 and a male
patient 11. The wearable monitor 12 sits centrally (in the midline)
on the patient's chest along the sternum 13 oriented top-to-bottom
with the monitor recorder 14 preferably situated towards the
patient's head. The electrode patch 15 is shaped to fit comfortably
and conformal to the contours of the patient's chest approximately
centered on the sternal midline 16 (or immediately to either side
of the sternum 13). The distal end of the electrode patch 15
extends towards the Xiphoid process and, depending upon the
patient's build, may straddle the region over the Xiphoid process.
The proximal end of the electrode patch 15, located under the
monitor recorder 14, is below the manubrium and, depending upon
patient's build, may straddle the region over the manubrium.
The placement of the wearable monitor 12 in a location at the
sternal midline 16 (or immediately to either side of the sternum
13) significantly improves the ability of the wearable monitor 12
to cutaneously sense cardiac electric signals, particularly the
P-wave (or atrial activity) and, to a lesser extent, the QRS
interval signals in the ECG waveforms that indicate ventricular
activity. The sternum 13 overlies the right atrium of the heart and
the placement of the wearable monitor 12 in the region of the
sternal midline 13 puts the ECG electrodes of the electrode patch
15 in a location better adapted to sensing and recording P-wave
signals than other placement locations, say, the upper left
pectoral region. In addition, placing the lower or inferior pole
(ECG electrode) of the electrode patch 15 over (or near) the
Xiphoid process facilitates sensing of right ventricular activity
and provides superior recordation of the QRS interval.
During use, the electrode patch 15 is first adhesed to the skin
along the sternal midline 16 (or immediately to either side of the
sternum 13). A monitor recorder 14 is then snapped into place on
the electrode patch 15 to initiate ECG monitoring. FIG. 3 is a
perspective view showing an extended wear electrode patch 15 in
accordance with one embodiment with a monitor recorder 14 inserted.
The body of the electrode patch 15 is preferably constructed using
a flexible backing 20 formed as an elongated strip 21 of wrap knit
or similar stretchable material about 145 mm long and 32 mm at the
widest point with a narrow longitudinal mid-section 23 evenly
tapering inward from both sides. A pair of cut-outs 22 between the
distal and proximal ends of the electrode patch 15 create a narrow
longitudinal midsection 23 or "isthmus" and defines an elongated
"hourglass"-like shape, when viewed from above, such as described
in commonly-assigned U.S. Design Patent application, entitled
"Extended Wear Electrode Patch," Ser. No. 29/472,045, filed Nov. 7,
2013, the disclosure of which is incorporated by reference. The
upper part of the "hourglass" is sized to allow an electrically
non-conductive receptacle 25, sits on top of the outward-facing
surface of the electrode patch 15, to be affixed to the electrode
patch 15 with an ECG electrode placed underneath on the
patient-facing underside, or contact, surface of the electrode
patch 15; the upper part of the "hourglass" has a longer and wider
profile than the lower part of the "hourglass," which is sized
primarily to allow just the placement of an ECG electrode.
The electrode patch 15 incorporates features that significantly
improve wearability, performance, and patient comfort throughout an
extended monitoring period. During wear, the electrode patch 15 is
susceptible to pushing, pulling, and torquing movements, including
compressional and torsional forces when the patient bends forward,
and tensile and torsional forces when the patient leans backwards.
To counter these stress forces, the electrode patch 15 incorporates
crimp and strain reliefs, as further described infra respectively
with reference to FIGS. 4 and 5. In addition, the cut-outs 22 and
longitudinal midsection 23 help minimize interference with and
discomfort to breast tissue, particularly in women (and
gynecomastic men). The cut-outs 22 and longitudinal midsection 23
allow better conformity of the electrode patch 15 to sternal bowing
and to the narrow isthmus of flat skin that can occur along the
bottom of the intermammary cleft between the breasts, especially in
buxom women. The cut-outs 22 and longitudinal midsection 23 help
the electrode patch 15 fit nicely between a pair of female breasts
in the intermammary cleft. In one embodiment, the cut-outs 22 can
be graduated to form the longitudinal midsection 23 as a narrow
in-between stem or isthmus portion about 7 mm wide. In a still
further embodiment, tabs 24 can respectively extend an additional 8
mm to 12 mm beyond the distal and proximal ends of the flexible
backing 20 to facilitate purchase when adhering the electrode patch
15 to or removing the electrode patch 15 from the sternum 13. These
tabs preferably lack adhesive on the underside, or contact, surface
of the electrode patch 15. Still other shapes, cut-outs and
conformities to the electrode patch 15 are possible.
The monitor recorder 14 removably and reusably snaps into an
electrically non-conductive receptacle 25 during use. The monitor
recorder 14 contains electronic circuitry for recording and storing
the patient's electrocardiography as sensed via a pair of ECG
electrodes provided on the electrode patch 15, such as described in
commonly-assigned U.S. patent application, entitled "Extended Wear
Ambulatory Electrocardiography and Physiological Sensor Monitor,"
Ser. No. 14/080,725, filed Nov. 14, 2013, pending, the disclosure
of which is incorporated by reference. The circuitry includes a
microcontroller, flash storage, ECG signal processing,
analog-to-digital conversion (where applicable), and an external
interface for coupling to the electrode patch 15 and to a download
station for stored data download and device programming. The
monitor recorder 14 also includes external patient-interfaceable
controls, such as a push button to facilitate event marking and a
resonance circuit to provide vibratory output. In a further
embodiment, the circuitry, with the assistance of the appropriate
types of deployed electrodes or sensors, is capable of monitoring
other types of physiology, in addition to ECGs. Still other types
of monitor recorder components and functionality are possible.
The non-conductive receptacle 25 is provided on the top surface of
the flexible backing 20 with a retention catch 26 and tension clip
27 molded into the non-conductive receptacle 25 to conformably
receive and securely hold the monitor recorder 14 in place. The
edges of the bottom surface of the non-conductive receptacle 25 are
preferably rounded, and the monitor recorder 14 is nestled inside
the interior of the non-conductive receptacle 25 to present a
rounded (gentle) surface, rather than a sharp edge at the
skin-to-device interface.
The electrode patch 15 is intended to be disposable. The monitor
recorder 14, however, is reusable and can be transferred to
successive electrode patches 15 to ensure continuity of monitoring.
The placement of the wearable monitor 12 in a location at the
sternal midline 16 (or immediately to either side of the sternum
13) benefits long-term extended wear by removing the requirement
that ECG electrodes be continually placed in the same spots on the
skin throughout the monitoring period. Instead, the patient is free
to place an electrode patch 15 anywhere within the general region
of the sternum 13.
As a result, at any point during ECG monitoring, the patient's skin
is able to recover from the wearing of an electrode patch 15, which
increases patient comfort and satisfaction, while the monitor
recorder 14 ensures ECG monitoring continuity with minimal effort.
A monitor recorder 14 is merely unsnapped from a worn out electrode
patch 15, the worn out electrode patch 15 is removed from the skin,
a new electrode patch 15 is adhered to the skin, possibly in a new
spot immediately adjacent to the earlier location, and the same
monitor recorder 14 is snapped into the new electrode patch 15 to
reinitiate and continue the ECG monitoring.
During use, the electrode patch 15 is first adhered to the skin in
the sternal region. FIG. 4 is a perspective view showing the
extended wear electrode patch 15 of FIG. 3 without a monitor
recorder 14 inserted. A flexible circuit 32 is adhered to each end
of the flexible backing 20. A distal circuit trace 33 from the
distal end 30 of the flexible backing 20 and a proximal circuit
trace (not shown) from the proximal end 31 of the flexible backing
20 electrically couple ECG electrodes (not shown) to a pair of
electrical pads 34. The electrical pads 34 are provided within a
moisture-resistant seal 35 formed on the bottom surface of the
non-conductive receptacle 25. When the monitor recorder 14 is
securely received into the non-conductive receptacle 25, that is,
snapped into place, the electrical pads 34 interface to electrical
contacts (not shown) protruding from the bottom surface of the
monitor recorder 14, and the moisture-resistant seal 35 enables the
monitor recorder 14 to be worn at all times, even during bathing or
other activities that could expose the monitor recorder 14 to
moisture.
In addition, a battery compartment 36 is formed on the bottom
surface of the non-conductive receptacle 25, and a pair of battery
leads (not shown) electrically interface the battery to another
pair of the electrical pads 34. The battery contained within the
battery compartment 35 can be replaceable, rechargeable or
disposable.
The monitor recorder 14 draws power externally from the battery
provided in the non-conductive receptacle 25, thereby uniquely
obviating the need for the monitor recorder 14 to carry a dedicated
power source. The battery contained within the battery compartment
35 can be replaceable, rechargeable or disposable. In a further
embodiment, the ECG sensing circuitry of the monitor recorder 14
can be supplemented with additional sensors, including an SpO.sub.2
sensor, a blood pressure sensor, a temperature sensor, respiratory
rate sensor, a glucose sensor, an air flow sensor, and a volumetric
pressure sensor, which can be incorporated directly into the
monitor recorder 14 or onto the non-conductive receptacle 25.
The placement of the flexible backing 20 on the sternal midline 16
(or immediately to either side of the sternum 13) also helps to
minimize the side-to-side movement of the wearable monitor 12 in
the left- and right-handed directions during wear. However, the
wearable monitor 12 is still susceptible to pushing, pulling, and
torquing movements, including compressional and torsional forces
when the patient bends forward, and tensile and torsional forces
when the patient leans backwards. To counter the dislodgment of the
flexible backing 20 due to compressional and torsional forces, a
layer of non-irritating adhesive, such as hydrocolloid, is provided
at least partially on the underside, or contact, surface of the
flexible backing 20, but only on the distal end 30 and the proximal
end 31. As a result, the underside, or contact surface of the
longitudinal midsection 23 does not have an adhesive layer and
remains free to move relative to the skin. Thus, the longitudinal
midsection 23 forms a crimp relief that respectively facilitates
compression and twisting of the flexible backing 20 in response to
compressional and torsional forces. Other forms of flexible backing
crimp reliefs are possible.
Unlike the flexible backing 20, the flexible circuit 32 is only
able to bend and cannot stretch in a planar direction. FIG. 5 is a
top view showing the flexible circuit 32 of the extended wear
electrode patch 15 of FIG. 3. A distal ECG electrode 38 and
proximal ECG electrode 39 are respectively coupled to the distal
and proximal ends of the flexible circuit 32. The flexible circuit
32 preferably does not extend to the outside edges of the flexible
backing 20, thereby avoiding gouging or discomforting the patient's
skin during extended wear, such as when sleeping on the side.
During wear, the ECG electrodes 38, 39 must remain in continual
contact with the skin. A strain relief 40 is defined in the
flexible circuit 32 at a location that is partially underneath the
battery compartment 36 when the flexible circuit 32 is affixed to
the flexible backing 20. The strain relief 40 is laterally
extendable to counter dislodgment of the ECG electrodes 38, 39 due
to tensile and torsional forces. A pair of strain relief cutouts 41
partially extend transversely from each opposite side of the
flexible circuit 32 and continue longitudinally towards each other
to define in `S`-shaped pattern, when viewed from above. The strain
relief respectively facilitates longitudinal extension and twisting
of the flexible circuit 32 in response to tensile and torsional
forces. Other forms of circuit board strain relief are
possible.
The flexible circuit 32 can be provided either above or below the
flexible backing 20. FIG. 6 is a perspective view showing the
extended wear electrode patch 15 in accordance with a further
embodiment. The flexible circuit (not shown) is provided on the
underside, or contact, surface of the flexible backing 20 and is
electrically interfaced to the set of electrical pads 34 on the
bottom surface of the non-conductive receptacle 25 through
electrical contacts (not shown) pierced through the flexible
backing 20.
The electrode patch 15 is intended to be a disposable component,
which enables a patient to replace the electrode patch 15 as needed
throughout the monitoring period, while maintaining continuity of
physiological sensing through reuse of the same monitor recorder
14. FIG. 7 is an exploded view showing the component layers of the
electrode patch 15 of FIG. 3. The flexible backing 20 is
constructed of a wearable gauze, latex, or similar wrap knit or
stretchable and wear-safe material 44, such as a Tricot-type linen
with a pressure sensitive adhesive (PSA) on the underside, or
contact, surface. The wearable material 44 is coated with a layer
43 of non-irritating adhesive, such as hydrocolloid, to facilitate
long-term wear. The hydrocolloid, for instance, is typically made
of mineral oil, cellulose and water and lacks any chemical
solvents, so should cause little itching or irritation. Moreover,
hydrocolloid is thicker and more gel-like than most forms of PSA
and provides cushioning between the relatively rigid and unyielding
non-conductive receptacle 25 and the patient's skin. In a further
embodiment, the layer of non-irritating adhesive can be contoured,
such as by forming the adhesive with a concave or convex
cross-section; surfaced, such as through stripes or crosshatches of
adhesive, or by forming dimples in the adhesive's surface; or
applied discontinuously, such as with a formation of discrete dots
of adhesive.
As described supra with reference to FIG. 5, a flexible circuit can
be adhered to either the outward facing surface or the underside,
or contact, surface of the flexible backing 20. For convenience, a
flexible circuit 47 is shown relative to the outward facing surface
of the wearable material 44 and is adhered respectively on a distal
end by a distal electrode seal 45 and on a proximal end by a
proximal electrode seal 45. In a further embodiment, the flexible
circuit 47 can be provided on the underside, or contact, surface of
the wearable material 44. Through the electrode seals, only the
distal and proximal ends of the flexible circuit 47 are attached to
the wearable material 44, which enables the strain relief 40 (shown
in FIG. 5) to respectively longitudinally extend and twist in
response to tensile and torsional forces during wear. Similarly,
the layer 43 of non-irritating adhesive is provided on the
underside, or contact, surface of the wearable material 44 only on
the proximal and distal ends, which enables the longitudinal
midsection 23 (shown in FIG. 3) to respectively bow outward and
away from the sternum 13 or twist in response to compressional and
torsional forces during wear.
A pair of openings 46 is defined on the distal and proximal ends of
the wearable material 44 and layer 43 of non-irritating adhesive
for ECG electrodes 38, 39 (shown in FIG. 5). The openings 46 serve
as "gel" wells with a layer of hydrogel 41 being used to fill the
bottom of each opening 46 as a conductive material that aids
electrode signal pick up. The entire underside, or contact, surface
of the flexible backing 20 is protected prior to use by a liner
layer 40 that is peeled away, as shown in FIG. 8.
The non-conductive receptacle 25 includes a main body 54 that is
molded out of polycarbonate, ABS, or an alloy of those two
materials to provide a high surface energy to facilitate adhesion
of an adhesive seal 53. The main body 54 is attached to a battery
printed circuit board 52 by the adhesive seal 53 and, in turn, the
battery printed circuit board 52 is adhesed to the flexible circuit
47 with an upper flexible circuit seal 50. A pair of conductive
transfer adhesive points 51 or, alternatively, metallic rivets or
similar conductive and structurally unifying components, connect
the circuit traces 33, 37 (shown in FIG. 5) of the flexible circuit
47 to the battery printed circuit board 52. The main body 54 has a
retention catch 26 and tension clip 27 (shown in FIG. 3) that
fixably and securely receive a monitor recorder 14 (not shown), and
includes a recess within which to circumferentially receive a die
cut gasket 55, either rubber, urethane foam, or similar suitable
material, to provide a moisture resistant seal to the set of pads
34.
While the invention has been particularly shown and described as
referenced to the embodiments thereof, those skilled in the art
will understand that the foregoing and other changes in form and
detail may be made therein without departing from the spirit and
scope.
* * * * *
References